CSL Behring announced that the Food and Drug Administration (FDA) has approved a new dosing option for Hizentra (immune serum globulin [human]) 0.2mg/mL (20%) Liquid to include treatment at regular intervals from daily to biweekly in patients with primary immunodeficiency.
In March 2010, Hizentra was approved as a once-weekly immunoglobulin G (IgG) replacement therapy, then as biweekly dosing in September 2013. Hizentra provides a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents. The exact mechanism of action in primary immunodeficiency is not fully known.
The FDA’s expanded approval was based on pharmacometrics; clinical trials that evaluated these alternative dosing regimens were not conducted.
Hizentra Liquid contains 0.2g protein/mL and is available in 5mL, 10mL, 20mL, and 50mL single-use vials.
For more information call (800) 504-5434 or visit Hizentra.com.